MedDataX Logo

Australian Screening Mammography Decision Aid Trial (ASMDAT)

NCT ID: NCT00247442

Last Updated: 2006-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mammography screening Breast cancer screening Screening outcomes Decision aid Decision support tool Informed choice

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decision aid

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.

Exclusion Criteria

* Inability to complete a telephone interview in English.
* Personal history of breast cancer (invasive and pre-invasive).
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sydney

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Davey, B.Psych, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Nehmat Houssami, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Erin Mathieu, B.Ed, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Andrew Page, BA (Hons)

Role: PRINCIPAL_INVESTIGATOR

BreastScreen NSW

Richard Taylor, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

BreastScreen NSW

Sian Smith, BSc (Hons)

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Phyllis Butow, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Sydney

Sydney, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

References

Explore related publications, articles, or registry entries linked to this study.

Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.

Reference Type DERIVED
PMID: 38726892 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CD-9999999

Identifier Type: -

Identifier Source: org_study_id